Advisor/ Sr. Advisor –Synthetic chemistry Process development - Scientist

Overview

Lead technical aspects of drug substance process optimization, technical transfers and the development of the technical agenda for small molecule manufacturing, within the Manufacturing and Quality technical hub in Hyderabad.

What you'll do

• Work with the team on process development of manufacturing processes.
• Leverage internal and external expertise to improve existing production processes.
• Establish a world class methodology to ensure new manufacturing processes are robust, cost effective and can be transitioned safely and rapidly into production.
• Lead the successful transfer of new processes or steps into production across the globe.
• Maintain a thorough understanding of the state of the art of manufacturing and regulatory requirements and build these into processes.
• Develop strong working relationships with both R&D and plant sites to ensure success.
• Serve as a member of multidisciplinary product development teams responsible for the commercial scale development of new processes, typically directing the laboratory activities and development of one or more junior staff members.
• Participate in the Science Lead Team as part of scientific governance and oversight, as needed.
• Provide technical stewardship on all products you are accountable for.
• Define and lead assigned technical projects (experimental, modelling, and/or production data analysis) to improve process control, yield, purity, and/or productivity.
• Work very closely with fellow scientists across disciplines and build a network of contacts across the corporation and the broader scientific community.

What you'll need

• Ph.D. in Organic Chemistry or Chemistry, or Ph.D. / Post Doc in Chemistry (focusing more on process chemistry).
• 5-12 years of experience.
• Proven track record of driving technical agendas and influence externally in the small molecule space.
• Comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP) and regulatory requirements.
• Demonstrated ability to commercialize and solve manufacturing problems.
• Hands-on experience supporting production at different scales, from both a commercialization and supply perspective.
• Proven track record of working with diverse groups across the value chain and in multiple locations.
• Understanding of the interaction of bulk drug substance and drug product formulation, and of the interaction of equipment sets with process (drug substance and drug product).
• Significant experience with registration, including authoring technical reports, Development History Reports, regulatory responses, or direct interactions with regulatory agencies.
• Understanding of the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
• Understanding of the chemistry and stability of peptides from a first principles perspective.
• Proven record of embracing advanced digitization efforts by deploying digital tools to enable advanced modelling and seamless digital technology transfer.
• Experience coaching and mentoring peers and other scientists.
• Interpersonal skills to work effectively with a broad spectrum of people.

Details

• Location: Hyderabad, India.
• Some travel (domestic and international), less than 5%, may be required.
• Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.